Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

University of Florida26 enrolled

Overview

The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.

The participants will undergo an Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy and evaluation of a bile duct or pancreatic duct stricture with three different types of techniques for biopsy: SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Accuracy of Tissue Diagnosis Bile Duct Stricture Pancreatic Duct Stricture

Interventions

ERCP with cholangiopancreatoscopyPROCEDURE

Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects is 18 years or older 2. Scheduled to undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) wiht cholangioscopy and/or pancreatoscopy at the University of Florida Gainesville Florida as medically indicated. 3. Lesion of the pancreatobiliary system that requires tissue sampling as medically indicated 4. Subject myst be able to give informed consent Exclusion Criteria: 1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP) 2. The subject is unable to give informed consent

Locations (1)

Shands at UF Ensopcopy

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Percentage of Participants With Accurate Diagnoses of Cancer

The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.

Time frame: up to 7 days after the procedure

Secondary Outcomes

Procedure Technical Success

The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.

Time frame: day 1

Total Procedure Time

The total time to perform ERCP

Time frame: 120 minutes

Total Cholangioscopy Time

This is the total time it takes for the dye to be performed during the ERCP.

Time frame: 60 minutes

Cholangioscopy Visualization Time

The portion of the total ERCP time spent on Cholangioscopy visualization.

Time frame: 30 minutes

Sampling Times for Each Device

The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).

Time frame: 15 minutes

Data from ClinicalTrials.gov

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